Percutaneous Coronary Intervention Program Research Articles

Impact of a dedicated radial lounge on same-day discharge percutaneous coronary intervention.

The same-day discharge (SDD) program after elective percutaneous coronary intervention (PCI) is a safe strategy that allows for the optimization of hospital resources. However, the lack of adequate infrastructure and a specially targeted care model may limit its implementation. Our center developed an outpatient care model based on an area designed for percutaneous procedures called radial lounge (RL). Evaluate the efficacy and safety of the RL care model: (1)SDD rate,(2) patient experience,(3) major adverse cardiac events (MACEs) (in-hospital, 30-day, and 1-year mortality andintervention),and (4) vascular access complication. Impact of RL SDD rate on total elective SDD-PCI volume. We conducted a retrospective observational cohort study at a cardiovascular hospital, including consecutive patients undergoing elective PCI between 2015 and 2022 who were admitted to the conventional hospitalization area (CHA) or the RL about the stated objectives. Patient experience was assessed using the Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey. A total of 5466 elective PCI procedures were included: 2102 in the RL and 3364 in the CHA. The SDD rate was 85.2% in the RL group and 54% in the CHA. After the implementation of RL, a significant increase in the volume of elective SDD-PCI was observed and patient satisfaction improved significantly (p < 0.005) with CHA. Finally, a greater amount of MACEs were not observed in the RL. The PCI program in RL proved to be safe and effective. It showed a higher rate of SDD and a significant improvement in patient experience was observed without affecting safety.

Impact of a Specifically Designed Model of Care in an Outpatient Coronary Angioplasty Program

Background: An outpatient model of care for percutaneous coronary procedures called Radial Lounge (RL) was designed at our center. Patients wear their own clothes throughout their stay, with no mobility restrictions and without fasting. Before and after the procedure, they remain in an armchair accompanied by a family member until discharge, without continuous monitoring, under the supervision of a nurse dedicated exclusively to this area. Objectives: The aim of this study was to evaluate the safety and efficacy of the RL model of care, the same-day discharge (SDD) rate, patient experience, and major adverse cardiovascular events (MACE): in-hospital mortality, overall mortality, and re-hospitalization at 30 days Methods: A retrospective observational cohort study was conducted at a cardiovascular center, including consecutively enrolled patients undergoing elective percutaneous coronary intervention (PCI) in the RL. Results: A total of 2102 elective PCI procedures were included under the RL model. The SDD rate was 85.3% in the first year of its implementation (2018) and reached 89% in 2022. Assessing patient experience, the average score obtained through the Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey was 9.61/10. The rate of MACE was not higher than that reported in the literature. Conclusion: The PCI program in the RL proved to be a safe and effective model in our experience.

Outpatient PCI - early discharge PCI, single center experience

Abstract Funding Acknowledgements None. Background Percutaneous coronary intervention (PCI) has undergone rapid evolution over the last years and is currently a widely generalized therapeutic option. In the past, it was associated with a significant rate of complications, yet, with the improvement of new generation drug eluting stents, and the radial access (RA) development, PCI has become safer and simpler, with a minimum rate of complications. This allows patient’s faster discharge. Besides the pressure from the limited number of beds in wards, the improvement of PCI has given the confidence to urge outpatient PCI programs. However, there are still centers where there is no ambulatory PCI. Purpose This study aims to describe our center experience of ambulatory PCI program, in terms of safety and efficacy. Methods We analyzed our center’s retrospective cohort of 723 PCI, in 2022. Ambulatory PCI was defined as PCI with same day hospital discharge. Our inclusion criteria were patients submitted to PCI. We excluded patients with acute coronary syndromes and patients needing hospital admission for other non-coronary reasons. Results 467 (65%), of the 723 PCI were performed in ambulatory setting. Patients mean age was 67,8±11 years and 23% (n=107) were female. In 12% (n=55) of the cases, the coronary anatomy was previously known, from a differed procedure. 63% (n=298) had a normal left ventricle ejection fraction (LVEF), 6% (n=26) had a moderate depression of LVEF and 3% (n=13) had LVEF severe depression. RA was possible in 82% of the cases (n=384), and 18% (n=83) of PCI was done by femoral access (FA). The access size was 6 Fr in 77% (n=359) of the cases, 7Fr in 22% (n=105) and 8Fr in 1% (n=2). The RA hemostasis was by compression (either manually or by external device) and FA hemostasis was first intended by closing device, however in 17% of the transfemoral PCI (n=14) had to be compressed, due to device hemostasis failure. PCI was successful in 97% of the cases (n=449), with revascularization of the goal lesion. The unsuccessful PCI (3% n=18) were because uncrossable lesion in 2% (n=14), and no reflow after PCI in 1% (n=4). 6 patients had to be admitted, after planned outpatient PCI, 5 due to peripheral access complication with hemorrhage of FA (after closing device and manual compression failure) and 1 due to PCI complication, with small coronary perforation. There was a higher probability of admission in patients submitted to transfemoral PCI (p&amp;lt;0,05), and there was no statistically significant relation between unplanned admission and patient’s LVEF. There were no episodes of death, MACE, non-planned hospital readmission and stent failure in the ambulatory PCI population. PCI has become a predictable and reliable technique, capable to treat outpatients. Patients undergoing successful non-complex PCI, without events, can safely be discharged on the same day. Outpatient PCI helps with the functioning of inpatient care, allowing beds to be freed up for other situations.

Implementation of a national primary percutaneous coronary intervention program for ST-segment elevation myocardial infarction in the Kingdom of Bahrain: an inspiring success story from a centre of excellence.

Implementation of a national primary percutaneous coronary intervention program for ST-segment elevation myocardial infarction in the Kingdom of Bahrain: an inspiring success story from a centre of excellence.

Government Regulation and Percutaneous Coronary Intervention Volume, Access and Outcomes: Insights From the Washington State Cardiac Care Outcomes Assessment Program

BackgroundIt is unclear how to geographically distribute percutaneous coronary intervention (PCI) programs to optimize patient outcomes. The Washington State Certificate of Need program seeks to balance hospital volume and patient access through regulation of elective PCI.Methods and ResultsWe performed a retrospective cohort study of all non‐Veterans Affairs hospitals with PCI programs in Washington State from 2009 to 2018. Hospitals were classified as having (1) full PCI services and surgical backup (legacy hospitals, n=17); (2) full services without surgical backup (new certificate of need [CON] hospitals, n=9); or (3) only nonelective PCI without surgical backup (myocardial infarction [MI] access hospitals, n=9). Annual median hospital‐level volumes were highest at legacy hospitals (605, interquartile range, 466–780), followed by new CON, (243, interquartile range, 146–287) and MI access, (61, interquartile range, 23–145). Compared with MI access hospitals, risk‐adjusted mortality for nonelective patients was lower for legacy (odds ratio [OR], 0.59 [95% CI, 0.48–0.72]) and new‐CON hospitals (OR, 0.55 [95% CI, 0.45–0.65]). Legacy hospitals provided access within 60 minutes for 90% of the population; addition of new CON and MI access hospitals resulted in only an additional 1.5% of the population having access within 60 minutes.ConclusionsMany PCI programs in Washington State do not meet minimum volume standards despite regulation designed to consolidate elective PCI procedures. This CON strategy has resulted in a tiered system that includes low‐volume centers treating high‐risk patients with poor outcomes, without significant increase in geographic access. CON policies should re‐evaluate the number and distribution of PCI programs.

Abstract 216: Outcomes Of Percutaneous Coronary Interventions In Patients With Chronic Total Occlusion (CTO): A Single Center Study Evaluating A New Dedicated CTO Program In Egypt

Background: Percutaneous coronary intervention (PCI) for a chronic total occlusion (CTO) is underutilized. Initiation of a dedicated, cost-oriented, CTO PCI program is challenging. Objectives: We present our experience in establishing a limited resources dedicated multi-operator CTO PCI program in a major tertiary academic center in Egypt. Methods: We analyzed the clinical, angiographic, and procedural characteristics of patients who underwent CTO PCI during the first year of our program. Major outcome was successful recanalization. Other outcomes include in-hospital mortality, stroke, peri-procedural myocardial infarction (MI), coronary perforation, and urgent need of coronary artery bypass grafting (CABG). Results: Sixty-four patients underwent CTO PCI. The median J-CTO score was 2 (0-5). Successful recanalization was achieved in 47 patients (73%). The most common cause of failure was failure of re-entry (46.7%). The mean number of wires per patients was 2.69+/-1.32, and the most successful crossing strategy was antegrade wire escalation (56.3%). The mean procedural time was 123 +/- 48.8 min, mean contrast volume was 359.03 +/- 151.9 and mean radiation dose was 9.4 +/-4.2 Gy. There was no in-hospital mortality nor stroke. We had one case (1.6%) with peri-procedural MI, and one patient who needed an urgent CABG. The cost ranged from 6520 Egyptian Pounds (EP) ($415) to 63, 720 EP ($4058), with a mean of 26,213 EP ($1670) (Table 1). Conclusion: A dedicated limited resources CTO PCI program, in a low-income country as Egypt, can probably be established with a good success rate and a low complication rate. Proctored program allows rational equipment utilization and growth of the operators’ experiences and skills.

Safety and effectiveness of introducing a robotic-assisted percutaneous coronary intervention program in a tertiary center: a prospective study.

Robotic-assisted percutaneous coronary intervention (PCI) is a novel technology that permits remote operation of interventional devices. However, little is known about the safety and effectiveness of introducing a robotic PCI program in a hospital already experienced in traditional coronary angioplasty. Prospective single-arm survey to assess the safety and effectiveness of robotic-assisted PCI in comparison to pre-defined performance goals. The study cohort comprised all consecutive cases treated with robotic PCI since its introduction. The safety primary endpoint was a composite of (I) overall death or (II) non-fatal adverse events related to target vessel complications (stent thrombosis, myocardial infarction, vessel perforation or cardiac tamponade, or repeat invasive treatment) during the index hospitalization. The efficacy primary endpoint was robotic-assisted procedural success, a composite of (I) successful dilatation of the target lesion and (II) successful robotic assistance, defined as absent non-planned manual conversion. A total of 83 patients and 112 lesions were prospectively enrolled. The rate of angiographic success was 99.1%. From these, 97 lesions (86.6%) were treated with only robotic PCI or with hybrid according to the pre-interventional plan. The rates of efficacy and safety primary endpoints were 85.7% and 2.4% respectively (P<0.01 for non-inferior to the pre-defined performance threshold). Introduction of robotic-assisted PCI in a tertiary center was associated with safe and effective results, comparable to pre-defined goals of optimal performance.

Contemporary Strategies and Outcomes of Dedicated Chronic Total Occlusion Percutaneous Coronary Intervention Programs: A Prospective Multicentre Registry.

Background The field of CTO PCI is expanding, but successful and safe percutaneous coronary intervention (PCI) of coronary chronic total occlusions (CTO) requires a substantial resource and experience investment. We aimed to assess temporal trends in strategies and outcomes of 2 dedicated programs for CTO PCI. Methods Between 2011 and 2020, 920 CTO PCI procedures were prospectively included at 2 referral centres in Belgium. Temporal trends were assessed, and logistic regression models were built to identify predictors of outcome. Results Despite an increase in lesion complexity (the J-CTO score increased from 1.3 in year 1 to 1.7–2.0 in years 8-9, p < 0.001), technical success improved from 70.0% to 85.6% in year 9 (p value for trend <0.001). We observed the most significant improvement starting at years 3-4 (OR 2.3 in year 4 versus year 1, p=0.018). Together with an increase in success rates and lesions complexity, there was an increase in the use of dual injections, retrograde approaches, the number of balloons and stents, and the use of microcatheters. Conversely, there was a decrease in large bore access, an increase in radial approach, and a shift towards contemporary dissection/reentry techniques. This strategy resulted in a stable major complication rate of 4.7% (p value for trend 0.33). The rate of coronary procedure-related myocardial injury was high (71.0%) and was associated with the use of more intracoronary devices. Conclusions Three to four years after initiation of a dedicated CTO PCI program with 50 CTO PCIs per year, consistent high technical success and low complication rates are achieved using contemporary strategies.

SCAI position statement on the performance of percutaneous coronary intervention in ambulatory surgical centers.

The Centers for Medicare & Medicaid Services (CMS) began reimbursement for percutaneous coronary intervention (PCI) performed in ambulatory surgical centers (ASC) in January 2020. The ability to perform PCI in an ASC has been made possible due to the outcomes data from observational studies and randomized controlled trials supporting same day discharge (SDD) after PCI. In appropriately selected patients for outpatient PCI, clinical outcomes for SDD or routine overnight observation are comparable without any difference in short-term or long-term adverse events. Furthermore, a potential for lower cost of care without a compromise in clinical outcomes exists. These studies provide the framework and justification for performing PCI in an ASC. The Society for Cardiovascular Angiography and Interventions (SCAI) supported this coverage decision provided the quality and safety standards for PCI in an ASC were equivalent to the hospital setting. The current position paper is written to provide guidance for starting a PCI program in an ASC with an emphasis on maintaining quality standards. Regulatory requirements and appropriate standards for the facility, staff and physicians are delineated. The consensus document identified appropriate patients for consideration of PCI in an ASC. The key components of an ongoing quality assurance program are defined and the ethical issues relevant to PCI in an ASC are reviewed.

Unprotected versus protected high-risk percutaneous coronary intervention with the Impella 2.5 in patients with multivessel disease and severely reduced left ventricular function.

Selecting a revascularization strategy in patients with multivessel disease (MVD) and severely reduced left ventricular ejection fraction (LVEF) remains a challenge. PCI with Impella 2.5 may facilitate high-risk PCI, however long-term results comparing unprotected versus protected PCI are currently unknown. We sought to evaluate the outcome of patients undergoing protected compared to unprotected percutaneous coronary intervention (PCI) in the setting of MVD and severely reduced LVEF.We included patients with MVD and severely reduced LVEF (≤35%) in this retrospective, single-centre study. Patients that underwent unprotected PCI before the start of a dedicated protected PCI program with Impella 2.5 were compared to patients that were treated with protected PCI after the start of the program. The primary endpoint was defined as major adverse cardiac and cerebrovascular events (MACCE) during a 1-year follow-up. The secondary endpoints consisted of in-hospital MACCE and adverse events.A total of 61 patients (mean age 70.7 ± 10.9 years, 83.6% male) were included in our study, of which 28 (45.9%) underwent protected PCI. The primary endpoint was reached by 26.7% and did not differ between groups (P = .90). In-hospital MACCE (P = 1.00) and in-hospital adverse events (P = .12) also demonstrated no significant differences. Multivariate logistic regression identified procedural success defined as complete revascularization and absence of in-hospital major clinical complications as protective parameter for MACCE (OR 0.17, 95% CI 0.04–0.70, P = .02).Patients with MVD and severely depressed LVEF undergoing protected PCI with Impella 2.5 demonstrate similar in-hospital and one-year outcomes compared to unprotected PCI.

Implementation of an Ambulatory Percutaneous Coronary Intervention Program in Higher Risk Patients

Implementation of an Ambulatory Percutaneous Coronary Intervention Program in Higher Risk Patients

Implementation of an Ambulatory Percutaneous Coronary Intervention Program in Higher Risk Patients

Introduccion: La implementacion de programas de Angioplastia Ambulatoria (AA) en pacientes tratados en forma electiva surge como una estrategia factible y segura. Sin embargo, la informacion sobre la implementacion de esta en pacientes con riesgo incrementado para el alta el mismo dia del procedimiento es limitada en la actualidad e incluso surge de publicaciones que podrian no reflejar el estado actual de la angioplastia coronaria. Objetivo: Evaluar la seguridad y factibilidad de un programa de AA en pacientes programados con riesgo incrementado para alta precoz. Metodo: Estudio observacional, unicentrico que incluyo pacientes tratados con angioplastia coronaria electiva entre Enero 2009 – Marzo 2017. La presencia de riesgo incrementado para AA se definio de acuerdo al consenso del SCAI de estadia hospitalaria post angioplastia coronaria. Para evaluar la seguridad de la intervencion se comparo la cohorte de pacientes electivos comprendida entre Enero 2009 - Octubre 2015 ( cohorte pre-intervencion ) con aquellos pacientes incluidos en el programa de AA desde su inicio en Noviembre 2015 - Marzo 2017 ( cohorte intervencion ). Para evaluar la factibilidad se dividio la cohorte intervencion en dos grupos segun el tiempo de internacion: los que fueron dados de alta el mismo dia ( grupo alta precoz, GAP ) y los que continuaron su hospitalizacion hasta el dia siguiente ( grupo hospitalizacion, GH ). Resultados: Se incluyeron 3663 pacientes, de los cuales 2422 presentaban riesgo incrementado para AA en la cohorte pre-intervencion y 661 en la cohorte intervencion . La prevalencia de Muerte/IAM/ACV a los 7 dias fue similar en ambos grupos (cohorte intervencion 0.5% vs. cohorte pre-intervencion 0.5% [HR 1.04, IC95% 0.29 - 3.75], p 0.94. No se observaron diferencias en la necesidad de rehospitalizacion (cohorte intervencion 0.9% vs. cohorte pre-intervencion 1.7% [HR 0.53, IC95% 0.22 - 1.27], p 0.15). En el analisis de factibilidad, el GAP represento el 52.1% de la cohorte intervencion, con una reduccion significativa del 73% del tiempo de hospitalizacion (GH 19.4 hrs, RI 17.22 - 22.7 vs. GAP 7.27 hrs, RI 5.8 - 9.1, p < 0.0001) y un 23% en los costos. El tiempo de internacion en el GAP se incremento con la mayor carga de factores de riesgo (FR) para AA: 1 FR: 6.8 hrs, RI 5.6 - 8.1, 2 FR: 7.1 hrs, RI 5.7 - 9.02, ≥3 FR: 7.7 hrs, RI 6.4 - 11.5, p trend 0.002. En el GH las causas de observacion hasta el dia siguiente fueron: 30,4% comorbilidades, 20,3% intervenciones complejas y el 23,4% a causas sociales. Conclusion: La implementacion de nuestro programa de AA en esta poblacion se asocio a similares tasas de eventos mayores y de re-hospitalizacion que en los pacientes abordados de forma estandar. La reduccion evidenciada en los tiempos y los costos de internacion podrian impactar positivamente en la eficiencia operativa de la institucion.

Incidence and characteristics of inappropriate and false-positive cardiac catheterization laboratory activations in a regional primary percutaneous coronary intervention program

The implementation of regional primary percutaneous coronary intervention (PCI) programs has been critical in achieving timely intervention in patients with ST-segment elevation myocardial infarction (STEMI). However, 1 consequence has been inappropriate and false-positive cardiac catheterization laboratory (CCL) activations where either angiography is cancelled or no culprit lesion is found, respectively. We performed a retrospective cohort study of 1,391 patients referred for primary PCI to a single academic center from November 2007 to August 2013. Our purpose was to determine the incidence and characteristics of inappropriate and false-positive CCL activations by emergency departments (EDs) or emergency medical services (EMS), and the effect of a quality improvement (QI) initiative to reduce such events implemented during this period. During the study period, there were 37 (2.7%) inappropriate and 206 (14.8%) false-positive CCL activations. There was no difference between the ED and EMS rates of inappropriate activation (2.1% vs 3.8%, P = .06). Among patients who proceeded to angiography, the false-positive rate for ED CCL activation was 16.9% compared to 11.5% for EMS (P = .01). Although there was no difference comparing inappropriate activation or false-positive rates before and after the QI initiative (P = .22), we observed an encouraging year-to-year trend. Emergency department activation of the CCL is associated with a higher false-positive rate than activation by EMS. Further QI efforts are required to improve communication between interventional cardiologists, emergency physicians, and paramedics to improve the specificity of CCL activation while taking care not to sacrifice sensitivity and rapidity of diagnosis.

Current State of Radial Artery Catheterization in ST-Elevation Myocardial Infarction

A well-established body of evidence demonstrating the advantages of a transradial approach for coronary angiography and intervention has led to worldwide adoption of this technique. In some countries, radial access has replaced femoral access as the dominant access site for percutaneous coronary intervention (PCI). More recently, numerous randomized controlled trials have compared transradial and transfemoral access in patients with ST elevation myocardial infarction (STEMI) and have shown that transradial access is associated with lower mortality and less major bleeding. This review examines the advantages of transradial primary PCI for STEMI patients, addresses concerns in adopting this approach for primary PCI, and reviews recommendations on how to start a transradial primary PCI program.

Thirty years of standalone percutaneous coronary interventions: A 23,261 case experience from a Canadian tertiary referral centre

Background: When percutaneous coronary intervention (PCI) was first performed >35 years ago, on-site cardiac surgery backup for PCI failure was deemed essential. As techniques improved and primary PCI became the preferred reperfusion strategy for acute myocardial infarction, many standalone PCI programs originally established to facilitate access to primary PCI started to perform elective PCI, which remains a Class IIb recommendation in American College of Cardiology Foundation/American Heart Association/Society for Cardiac Angiography and Interventions guidelines. Two recent United States studies showed that outcomes of elective PCI in standalone centres were noninferior to those with on-site cardiac surgery. The Royal Alexandra Hospital in Edmonton (Alberta) performed the first standalone PCI in Canada in 1981. Objectives: The authors describe their first 30 years’ experience with PCI – the largest single-centre standalone experience reported to date. Methods: Patient and procedural data have been collected since the first standalone PCI in 1981, evolving from paper records to a computer database and, in 1995, a provincial database. Quality assurance and peer review in collaboration with the regional cardiac surgery program was established from the outset. Results: The success, emergency coronary bypass and death rates for 23,261 standalone PCIs performed between 1981 and 2011 were 96.0%, 0.2% and 0.5%, respectively. For 9068 PCIs performed between 2007 and 2011 (a period that most reflects contemporary practice), the rates were 96.5%, 0.04% and 0.6%, respectively. These results compare favourably with PCI results reported in literature, irrespective of the presence or absence of on-site cardiac surgery. Conclusions: With high volumes and an experienced team, standalone PCIs can be performed safely with excellent success and low complication rates.

Results of a Stand-Alone PCI Program at Schneider Regional Medical Center

Percutaneous coronary intervention (PCI) is a class I recommended therapy for both ST segment elevation myocardial infarction (STEMI) and unstable angina. Traditionally, PCI has been performed in large tertiary centers with on-site coronary bypass surgery programs. Over the past 10 to 15 years, “stand-alone” PCI programs have become more prevalent, particularly in the United States. Geographic, cultural, and financial challenges prohibit routine transfer to tertiary centers in a timely fashion. This article discusses the PCI program at Schneider Regional Medical Center.

A cross-sectional study of stand-alone percutaneous coronary intervention in a Nigerian cardiac catheterization laboratory.

BackgroundThere is a paucity of diagnostic and therapeutic facilities in Nigeria to confirm coronary artery disease and offer appropriate interventional therapy. There is now a private cardiac catheterization laboratory in Lagos but as there are no sustained Open Heart Surgery programmes, percutaneous coronary interventions are currently being performed without surgical backup. This study was designed to assess results of stand-alone percutaneous coronary intervention (PCI) as currently practiced in Lagos, Nigeria.MethodsThis cross-sectional study was conducted between July 2009 and July 2012. The study included all patients that underwent PCI in Lagos. Data was extracted from a prospectively maintained database.ResultsCoronary artery disease was confirmed in 80 (52.6%) of 152 Nigerians referred with a diagnosis of Ischaemic Heart Disease. There were 53 males (66.2%) and 27 females (33.8%). The average age was 60.3 +/−9.6 years and average euroscore was 4.5 +/−3.1. Of the 80 patients, 77 (96.3%) had significant stenoses and were candidates for revascularization. Distribution of significant stenoses was one in 32 patients (41.5%), two in 11 patients (14.3%), three in 19 patients (24.7%), four in 13 patients (16.9%) and five in 2 patients (2.6%). PCI was performed in 48 (62.3%) of the patients eligible for revascularization as the coronary anatomy in the remaining patients was not suitable for PCI. The indication for PCI was for myocardial infarction or unstable angina in 39 patients (81.2%). PCI was performed with PTCA plus stenting in 41 patients (85.4%) and with PTCA alone in 7 patients (14.6%) with good angiographic results. Overall 29 of the 48 patients (60.4%) had complete revascularization of significant stenoses. Complications of PCI were bleeding that required blood transfusion in 1 patient (2.1%), minor femoral haematomas in 2 patients (4.2%), and a major adverse clinical event in 1 patient (2.1%).ConclusionA stand-alone PCI programme has been developed in Lagos, Nigeria. Both elective and urgent PCIs have been performed with no mortalities and a low complication rate. Increased volumes will however accrue and complete revascularization rates would be improved with the establishment of Open Heart Surgery programmes to provide CABG as back-up for PCI and alternate therapy for more complex lesions.

The first year of the Venlo percutaneous coronary intervention program: procedural and 6-month clinical outcomes

ObjectivesAnalysis of the first results of off-site percutaneous coronary interventions (PCI) and fractional flow reserve (FFR) measurements at VieCuri Medical Centre for Northern Limburg in Venlo.BackgroundOff-site PCI is accepted in the European and American Cardiac Guidelines as the need for PCI increases and it has been proven to be a safe treatment option for acute coronary syndrome.MethodsRetrospective cohort study reporting characteristics, PCI and FFR specifications, complications and 6-month follow-up for all consecutive patients from the beginning of off-site PCI in Venlo until July 2012. If possible, the data were compared with those of Medical Centre Alkmaar, the first off-site PCI centre in the Netherlands.ResultsOf the 333 patients, 19 (5.7 %) had a procedural complication. At 6 months, a major adverse cardiovascular event (MACE) occurred in 43 (13.1 %) patients. There were no deaths or emergency surgery related to the PCI or FFR procedures. There was no significant difference in occurrence of a MACE or adverse cerebral event between the Alkmaar and Venlo population in the 30-day follow-up.ConclusionThis study demonstrates off-site PCI at VieCuri Venlo to have a high success rate. Furthermore, there was a low complication rate, low MACE and no procedure-related mortality.

Percutaneous coronary intervention without surgery on-site is here to stay.

The need for emergency cardiac bypass surgery due to a complication occurring during a PCI procedure has gone down from an initial 6–10 % in the early 1980s to less than 0.5 % in the present era [1]. Technological advances have made the procedure very safe in the hands of experienced operators working in dedicated centres. In Europe in the last decade, many PCI programs without surgery on-site have been started as a consequence of this rare need for actual surgical back-up. In addition, these PCI programs were started in (mostly rural) regions where travel distances to PCI centres with surgery on-site resulted in long delays for STEMI patients undergoing primary PCI. The safety and long-term efficacy outcome of PCI programs in centres without surgery on-site have been shown in registries and large randomised studies. Just recently, the MASS COMM investigators demonstrated in a large randomised trial including 3691 patients that there was no difference in the incidence of MACE at 30 days (9.5 % vs 9.4 %; RR 1.00; P < 0.001 for non-inferiority) and at 12 months (17.3 % vs 17.8 %; RR 0.98; P < 0.001 for non-inferiority) [2]. These data confirm and extend the results from the CPORT study published in 2012, which randomised 18,867 patients and showed no difference in 6-week mortality and no difference in MACE at 9 months (12.1 % vs 11.2 %; P = 0.05) [3]. Both these studies excluded patients undergoing urgent PCI procedures for STEMI and NSTEMI. Reports using non-randomised data from the NRMI database by Pride et al., which included 58,821 STEMI patients and more than 100,000 NSTEMI patients treated either in centres with or without surgery on-site confirmed that the safety (e.g., as assessed on the basis of short-term mortality and need for emergency surgery) and efficacy (e.g., procedural success and longer-term rate of survival) of such PCI procedures was similar [4, 5]. Following these developments, the Dutch Guidelines for Interventional Cardiology 2004 included recommendations for centres and operators that provide PCI without surgery on-site regarding facilities, staffing, training requirements etc [6]. The minimum number of procedures per centre and per operator are required in order to ensure proficiency, experience and continued quality of care. Moreover, structural relations with a surgical centre and protocols for emergency transfer should be present. In order to provide primary PCI for patients with STEMI, a 24–7 service is required and finally, centres are obliged to prospectively register procedures and outcomes and submit these data to the Dutch Society of Cardiology. In this issue of the Netherlands Heart Journal, the experience of the first year of PCI procedures of the Venlo Percutaneous Coronary Intervention Program at VieCurie Medical Centre Venlo and the six-month clinical outcome is reported by Mol et al [7]. A total of 333 patients were included and, as expected, the incidence of procedural complications and MACE at 6 months was low, 5.7 % and 13.1 % respectively. The results at 30 days were comparable to the earlier report by Mol et al [7] from the Medical Center Alkmaar. The authors are to be commended that they report their results, illustrating efficacy and safety of a PCI program without surgery on-site. Together with the data from the literature, we can conclude that PCI without surgery on-site is safe for selected patients when performed in experienced hands in dedicated centres. It is convenient for patients to be treated in a hospital nearby, and for ACS patients it is probably cost-saving as it avoids ambulance transfers. Several questions regarding the future quality of care in PCI programs remain:

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